Pilot the Use of VA Make the Connection Campaign to Facilitate Help Seeking Among Vulnerable Veterans

• ClinicalTrials.gov Identifier: NCT03407443
• Recruitment Status: Active, not recruiting
• First Posted: January 23, 2018
• Last Update Posted: July 27, 2021
• Sponsor: Canandaigua VA Medical Center
• Information provided by (Responsible Party): Elizabeth Karras, Canandaigua VA Medical Center

Study Description

Brief Summary:

This pilot study seeks to determine if exposure to the Make the Connection campaign messages developed by the U.S. Department of Veterans Affairs (VA) is associated with changes in mental-health related outcomes, specifically: (1) psychosocial determinants that drive help seeking behaviors (knowledge, attitudes and intentions); and (2) perceived barriers to seeking care. Participants are randomly assigned to message exposure or control (no exposure) conditions. Data from this project will inform mental health education and outreach efforts targeted towards Veterans experiencing mental health concerns.

Condition or disease	Intervention/treatment	Phase
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse); Help-Seeking Behavior	Other: Exposure to Make the Connection messages; Other: Active Control Group	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Evaluation of the VA's Public Awareness Campaigns
• Actual Study Start Date: July 2016
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: September 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exposure to Make the Connection messages	Other: Exposure to Make the Connection messages; Participants are exposed to Make the Connection messages (each approximately 3 minutes in length) weekly for over a four-month study period through the study mobile application.
Active Comparator: Active Control group	Other: Active Control Group; Participants are exposed to VA news clips/segments (each approximately 3 minutes in length) weekly for over a four-month study period through the study mobile application.
No Intervention: No exposure control group

Outcome Measures

Primary Outcome Measures :

1. change in help seeking behavior [ Time Frame: change from baseline behavior at 16 weeks ]
   self-report treatment engagement in VA or non-VA services

Secondary Outcome Measures :

1. Attitudes towards help seeking [ Time Frame: assessed up to 16 weeks ]
   self-reported treatment beliefs and likelihood for help seeking
2. Barriers to care [ Time Frame: assessed up to 16 weeks ]
   The 6-item stigma Scale developed by Britt et al. (2000; 2008) to assess stigma of accessing treatment for psychological problems among military personnel is used w/a 5 point likert scale (1=strongly disagree to 5=strongly agree). Logistical barriers to care are also assessed using the 5-item Barriers to Care scale (Hoge et al. 2004) to assess barriers to accessing psychological treatment w/ a 5 point likert scale (1=strongly disagree; 5= strongly agree). Higher values represent a worse outcome (e.g., higher endorsement of stigma).

Other Outcome Measures:

1. change in social support [ Time Frame: change from baseline behavior at 16 weeks ]
   self-report survey using the multidimensional scale of perceived social support (Zimmet et al. 1990). This is a 12-item scale of perceived social support from family and friends. Each item is scored 1-7 on a likert scale (1=very strongly disagree; 7=very strongly agree) and summed with a possible range of 7 to 84. Higher scores indicate higher awareness/belief of social support.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Veterans of all gender/sex, race/ethnicities that in the past 6 months:

• utilized health services in the U.S. Department of Veterans Affairs (VA);
• screened positive on the PHQ-2, AUDIT-C or PC-PTSD and/or received a mental health diagnosis as documented in VA medical record
• Fluent in English language
• Capable of understanding goals of study
• Capable of providing verbal consent
• Willing and able to download/use study Android mobile application for duration of study

Exclusion Criteria:

• Not a U.S. Veteran who has utilized VA health care in the past 6 months
• Did not screen positive and/or was not diagnosed with mental health disorder
• Determined cognitively impaired and unable to provide verbal consent
• Determined to be in high distress during recruitment screening
• Currently institutionalized (i.e., hospitalized; incarcerated, etc.)
• Unwilling and/or unable to download and use use the study app

Contacts and Locations

Sponsors and Collaborators

Canandaigua VA Medical Center

Investigators

• Principal Investigator: Elizabeth Karras, PhD; Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center; U.S. Department of Veterans Affairs

More Information

• Responsible Party: Elizabeth Karras, Health Science Specialist, Canandaigua VA Medical Center
• ClinicalTrials.gov Identifier: NCT03407443
• Other Study ID Numbers: IRB899190
• First Posted: January 23, 2018
• Last Update Posted: July 27, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Karras, Canandaigua VA Medical Center:

mental health promotion campaign; veterans

Additional relevant MeSH terms:

Substance-Related Disorders; Personality Disorders; Mental Disorders; Chemically-Induced Disorders